Regulatory Oversight and Compliance

The agency published guidance to help pharma companies in the clinical development of treatments for bacillus Calmette-Guerin (BCG)-unresponsive nonmuscle invasive bladder cancer.

The half-cycle method for validating sterilization can have adverse effects on materials if used for steam sterilization.

In InstantGMP, cloud-based IT and an approach grounded in cGMPs, brings more of the power of paperless recordkeeping to manufacturers, at a fraction of the cost.

The agency recommended nine drugs including treatments for diabetes, hepatitis B, and HIV.

What’s ahead for the healthcare and pharmaceutical industries?

FDA puts Beijing Taiyang Pharmaceutical Industry Co. on import alert after company refuses access to inspectors.

NICE recommended eribulin for the treatment of patients with breast cancer, reversing its 2012 decision.

Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to prepare for an inspection by a foreign regulatory agency.

The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process.

Reliable, high-quality products require innovative analytics and production.

Recent astronomical price increases have driven accusations that some pharma companies are price-gouging.

Robust data integrity begins with both management and employees embracing a quality culture and successful implementation of data governance measures.

Douglas C. Throckmorton, MD, provides some key facts about abuse-deterrent opioids.

The Czech Republic drug manufacturer was cited for data integrity and quality issues.

FDA leaders insist that the decision to approve Sarepta’s Exondys (eteplirsen) should not be considered a model for future development of orphan drugs.

The new guidelines will address bioanalytical method validation and biopharmaceutics classification system-based biowaivers.

The guidance assists applicants in preparing prior approval supplements for abbreviated new drug applications.

The agency recommended granting conditional marketing authorization of Ocaliva for the treatment of primary biliary cholangitis.

The agency awarded 21 new clinical trial research grants to boost the development of treatments for rare diseases.

FDA is working with EMA to treat rare diseases and keep patients involved in healthcare.

Laboratoire Sintyl S.A. received an FDA warning letter for CGMP quality violations.

HHS entered into a contract with BioProtection Systems Corp. for commercial manufacturing tests of an Ebola vaccine.

The authors describe some cases of container closure design flaws and actions taken by FDA to mitigate safety risks and increase patient acceptability.

The agency’s Patient-Focused Drug Development program completed its commitment ahead of schedule.

Value assessment initiatives are expected to have a major impact on drug use and reimbursement.